UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): February
20, 2014
ARIAD
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
001-36172 |
22-3106987 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
26 Landsdowne Street, Cambridge, Massachusetts |
02139 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including
area code: (617) 494-0400
Not
Applicable
(Former
name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
ITEM 1.02 | Termination of a Material Definitive Agreement. |
On February 20, 2014, ARIAD Pharmaceuticals, Inc. (the “Company”) received from Merck, Sharpe & Dohme Corp. (“Merck”) a notice of termination (the “Notice”) of the Amended and Restated Collaboration and Exclusive License Agreement, dated May 4, 2010, between the Company and Merck (the “Agreement”). Under the Agreement, the Company had granted Merck an exclusive license to develop, manufacture and commercialize ridaforolimus in oncology, and Merck assumed responsibility for all activities related to the development, manufacture and commercialization of ridaforolimus and agreed to fund 100 percent of all ridaforolimus costs incurred after January 1, 2010. The Agreement provided that Merck would develop ridaforolimus in multiple oncology indications. In addition, under the Agreement, Merck had paid the Company $75 million in up front and milestone payments and had agreed to pay the Company potential additional milestone payments of up to $289 million associated with potential regulatory filings and approvals and up to $200 million associated with the achievement of certain sales thresholds, subject to regulatory approval and commercialization of ridaforolimus.
Merck delivered the Notice pursuant to the provisions in the Agreement allowing it to terminate the Agreement for convenience upon nine months’ written notice, and so the termination will be effective on November 20, 2014. Upon termination of the Agreement, rights to ridaforolimus will be returned to the Company. As provided in the Agreement, the parties will agree upon and implement plans for the orderly transition of development, manufacturing and commercialization of ridaforolimus from Merck back to the Company.
ITEM 2.02 | Results of Operations and Financial Condition. |
In a press release dated February 25, 2014, the Company announced financial results for the fourth quarter and year ended December 31, 2013, financial guidance for 2014, and an update on corporate developments. A copy of the press release is attached hereto as Exhibit 99.1. The information under the headings “2013 Fourth Quarter and Full-Year Financial Results” and “Today’s Conference Call at 8:30 a.m. ET” and the condensed consolidated financial information included in the press release are incorporated by reference into this Item 2.02 of this Current Report on Form 8-K.
ITEM 7.01 | Regulation FD Disclosure. |
In the press release dated February 25, 2014, the Company also provided information regarding financial guidance for 2014 as well as upcoming investor meetings. The information set forth under the headings “Financial Guidance for 2014” and “Upcoming Investor Meetings” in the press release are incorporated by reference into this Item 7.01 of this Current Report on Form 8-K.
ITEM 8.01 | Other Events. |
In the press release dated February 25, 2014, the Company also provided an update on its Iclusig® and AP26113 programs, its discovery research program and ridaforolimus, including Merck’s notice of termination of the parties’ license agreement referred to above. The second paragraph of the press release and the information set forth under the headings “Recent Progress and Key Objectives” together with the information contained in Item 1.02 above and the forward-looking statement disclaimer at the end of the press release, are incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
ITEM 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit | ||
Number |
Description |
|
99.1 | Press release dated February 25, 2014. |
The press release contains hypertext links to information on our websites. The information on our websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.
The portions of the press release incorporated by reference into Item 8.01 of this Current Report on Form 8-K are being filed pursuant to Item 8.01. The remaining portions of the press release are being furnished pursuant to Items 2.02 and 7.01 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act except as shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ARIAD Pharmaceuticals, Inc. |
|||||
|
|
By: |
/s/ Edward M. Fitzgerald |
||
Edward M. Fitzgerald |
|||||
Executive Vice President, Chief Financial Officer |
|||||
Date: |
February 25, 2014 |
Exhibit 99.1
ARIAD Reports 2013 Financial Results and Outlines Key Objectives for 2014
Conference Call Scheduled Today at 8:30 a.m. ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 25, 2014--ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today reported financial results for the fourth quarter and full year ended December 31, 2013 and provided an update on corporate developments.
“I am extremely pleased with the commercial and R&D progress we made in 2013, especially ending the year with Iclusig commercially available to refractory Philadelphia-positive leukemia patients in the United States. We are off to a strong start with our re-launch in the U.S. and are building momentum in Europe,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “As we advance into 2014, we are focused on building shareholder value and executing a fiscally responsible operating plan.”
Recent Progress and Key Objectives
Commercialization of Iclusig®
Iclusig Clinical Development
Advancing AP26113
Next Oncology Drug Candidate
Ridaforolimus
2013 Fourth Quarter and Full-Year Financial Results
Product Revenues
Net Loss
Quarter Ended December 31, 2013
Year Ended December 31, 2013
Cash Position
Financial Guidance for 2014
We anticipate cash used in operations in 2014 to range from $165 million to $175 million. Our guidance includes:
Upcoming Investor Meetings
ARIAD management will be making corporate presentations at the following investor conferences:
Today’s Conference Call at 8:30 a.m. ET
We will hold a live webcast and conference call of our fourth quarter/year-end 2013 financial results this morning at 8:30 a.m. ET. The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 888-771-4371 (domestic) or 847-585-4405 (international) five minutes prior to the start time and providing the pass code 36613162. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.
About Iclusig® (ponatinib) tablets
Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.
Important U.S. Safety Information for Iclusig® (ponatinib)
WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY
See full U.S. prescribing information for complete boxed warning
Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).
This press release contains “forward-looking statements” including, but not limited to, updates on clinical, preclinical and regulatory developments and commercialization plans for our products and product candidates and financial guidance for 2014. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, difficulties or delays in obtaining regulatory and pricing and reimbursement approvals to market our products; our ability to successfully commercialize and generate profits from sales of Iclusig; competition from alternative therapies, our reliance on the performance of third-party manufacturers and specialty pharmacies for the distribution of Iclusig; the occurrence of adverse safety events with our products and product candidates; our ability to meet anticipated clinical trial commencement and completion dates; delays in or failure of obtaining regulatory clearance for resumption of clinical trials; preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies; the costs associated with our research, development, manufacturing and other activities; the conduct and results of preclinical and clinical studies of our product candidates; the adequacy of our capital resources and the availability of additional funding; patent protection and third-party intellectual property claims; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risk factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.
ARIAD PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) |
|||||||||||||||||||||||
In thousands, except per share data |
Three Months Ended
December 31, |
Year Ended
December 31, |
|||||||||||||||||||||
2013 |
|
2012 | 2013 | 2012 | |||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Product revenue, net | $ | 8,281 | $ | --- | $ | 45,238 | $ | --- | |||||||||||||||
Other revenue | 72 | 74 | 323 | 558 | |||||||||||||||||||
Total revenue | 8,353 | 74 | 45,561 | 558 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of product revenue | 8,699 | --- | 9,612 | --- | |||||||||||||||||||
Research and development | 35,824 | 37,689 | 162,900 | 144,709 | |||||||||||||||||||
Selling, general and administrative | 37,637 | 22,915 | 146,615 | 60,909 | |||||||||||||||||||
Total operating expenses | 82,160 | 60,604 | 319,127 | 205,618 | |||||||||||||||||||
Other income (expense), net | (172 |
) |
|
77 | (153 |
) |
|
(15,812 | ) | ||||||||||||||
Provision for income taxes | 184 | --- | 439 | -- | |||||||||||||||||||
Net loss | $ | (74,163 |
) |
|
$ | (60,453 | ) | $ | (274,158 |
) |
|
$ | (220,872 | ) | |||||||||
Net loss per common share: | |||||||||||||||||||||||
-- basic and diluted | $ | (0.40 |
) |
|
$ | (0.36 | ) | $ | (1.49 |
) |
|
$ | (1.34 | ) | |||||||||
Weighted-average number of shares of common stock outstanding: | |||||||||||||||||||||||
-- basic and diluted | 185,699 | 166,707 | 183,575 | 164,964 | |||||||||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION |
|||||||
In thousands |
December 31,
2013 |
December 31,
2012 |
|||||
Cash, cash equivalents and marketable securities | $ | 237,179 | $ | 164,414 | |||
Total assets | $ | 370,894 | $ | 180,193 | |||
Total liabilities | $ | 185,377 | $ | 67,342 | |||
Stockholders’ equity | $ | 185,517 | $ | 112,851 |
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS INFORMATION |
|||||||||||||
In thousands |
Year Ended
December 31, |
||||||||||||
2013 | 2012 | ||||||||||||
Net cash used in operating activities |
|
$ |
(221,882 | ) |
|
$ |
(153,681 | ) | |||||
Net cash provided by (used in) investing activities | 26,138 | (50,400 | ) | ||||||||||
Net cash provided by financing activities | 313,584 | 17,204 | |||||||||||
Effect of exchange rates on cash |
(40 |
) |
--- | ||||||||||
Net increase (decrease) in cash and cash equivalents |
|
$ |
117,800 |
|
$ |
(186,877 | ) |
CONTACT:
For Investors
Kendra Adams, 617-503-7028
Kendra.adams@ariad.com
or
For
Media
Liza Heapes, 617-621-2315
Liza.heapes@ariad.com